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Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Studies in breastfeeding mothers have demonstrated that there is significant and documented risk to the infant based on human experience, or it is a medication that has a high risk of causing significant damage to an infant. The risk of using the drug in breastfeeding women clearly outweighs any possible benefit from breastfeeding. The drug is contraindicated in women who are breastfeeding an infant.
Typical usage: Hyperlipidaemia,Cardiovascular risk reduction,Homozygous familial hypercholesterolaemia.
Side Effects: Headache, nausea, flatulence, heartburn, abdominal pain, diarrhoea/constipation.
Drug Interaction: May cause slight elevation of serum digoxin. May increase risk of bleeding when used with coumarins and fluindione.
Mechanism Of Action: Simvastatin is a prodrug metabolised in the liver to form the active ?-hydroxyacid derivative. This inhibits the conversion of HMG-CoA to mevalonic acid by blocking HMG-CoA reductase, an early and rate-limiting step in cholesterol biosynthesis. It reduces total cholesterol, LDL-cholesterol and triglycerides and increases HDL-cholesterol levels.
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